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Trial record 10 of 34 for:    Specific Language Impairment 1

Characterization of Auditory Processing Involved in the Encoding of Speech Sounds (PRODIPRICIDE)

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ClinicalTrials.gov Identifier: NCT02574299
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. The assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). The two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.

Condition or disease Intervention/treatment Phase
Language Impairment Hearing Loss Other: E-learning Device: Hearing aids fitting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Ascending and Descending Auditory Processing Involved in the Encoding of Speech Sounds in Adult and Children: Variability Related to Changes in Sensory Input or a Neurodevelopmental Disorder or Targeted Remediation
Study Start Date : October 16, 2014
Estimated Primary Completion Date : April 16, 2020
Estimated Study Completion Date : April 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 1: Normal hearing children without SLI, transversal group
Normal hearing children without Specific Language Impairment (SLI),Transversal group for test-retest measures
No Intervention: 2: Normal hearing children without SLI, longitudinal group
Normal hearing children without Specific Language Impairment (SLI), longitudinal group without training
3: Normal hearing children with SLI, longitudinal group
Normal hearing children with Specific Language Impairment (SLI), longitudinal group with training
Other: E-learning
Management of auditory processing disorders with serious game (E-learning)

No Intervention: 4: Normal hearing adults without SLI, transversal group
Normal hearing adults without Specific Language Impairment (SLI), transversal group for test-retest measures
No Intervention: 5: Normal hearing adults without SLI, longitudinal group
Normal hearing adults without Specific Language Impairment (SLI), longitudinal group without hearing aids (HA)
6: Hearing Impaired candidates for HA, longitudinal group
Hearing Impaired adult candidates for hearing aids (HA), longitudinal group with hearing aids (HA)
Device: Hearing aids fitting
Symmetrical hearing loss which are fitted with binaural hearing aids for the first time




Primary Outcome Measures :
  1. Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure) [ Time Frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline ]
    Spectro-temporal analysis of speech auditory brainstem and late responses : The speech brainstem and cortical responses are simultaneously obtained in response of different selected syllables from a continuum (selected by using a phonemic identification test) which is presented throughout a behavioral categorical procedure


Secondary Outcome Measures :
  1. Change from Baseline medial olivocochlear system (MOCS) functioning measured using the contralateral suppressive effect of transient evoked otoacoustic emissions (composite measure) [ Time Frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline ]
    Measurement of the contralateral suppressive effect of transient evoked otoacoustic emissions (expressed as Equivalent Attenuation)

  2. Change from Baseline dichotic skills measured using central auditory processing tests (composite measure) [ Time Frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline ]
    Presentation of different speech material to both ears simultaneously

  3. Change from Baseline speech-noise listening skills measured using logatomes tests (composite measure) [ Time Frame: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline ]
    Presentation of disyllabic words in presence of increasing noise levels



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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For all subjects:

  • native French speaker
  • no medical treatment for behavior or neurological disorders
  • normal or corrected vision
  • right-handed
  • normal otorhinolaryngology examination
  • valid affiliation to social security
  • no participation to another research study

For the normal-hearing subjects

  • normal tonal hearing thresholds
  • normal tympanometry

For the subjects without specific language impairment

  • aged from 6 ro 40
  • normal school attendance without scholastic retardation
  • normal intellectual level
  • normal for age reading skills
  • no delayed speech (expression & production)

For the children with specific language impairment

  • aged fom 8 to 18
  • persistent specific literacy difficulties with reading levels at least 18 months behind that of their peers
  • normal intellectual level

For the hearing impaired subjects

  • age from 18 to 70
  • first auditory rehabilitation
  • bilateral and symmetric hearing loss (±10 dB) with hearing thresholds between 0 and 25 dB at 0.25 kilohertz, 0 and 35 dB at 0.5 kilohertz, 0 and 50 dB at 1 kilohertz, 25 and 70 dB at 2 kilohertz, 25 and 80 dB at 3 kilohertz, 30 and 80 dB at 4 kilohertz

Exclusion Criteria:

  • non signed assent
  • treatment for depression, epilepsy, Parkinson's or alzheimer's disease during more than 6 months
  • physical health deficiency
  • mental retardation
  • neurological or psychiatric disease incompatible with testing procedure

For children

  • known problem of hearing loss or chronic middle ear disease whic compromized the hearing status
  • schooling in a foreign language
  • foreign language spoken at home with both parents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574299


Contacts
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Contact: Hung THAï-VAN, MD 0472110503 ext +33 hung.thai-van@gmail.com

Locations
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France
Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon Recruiting
Lyon, France, 69003
Contact: Hung THAÏ-VAN, MD    0472110503 ext +33    hung.thai-van@gmail.com   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02574299     History of Changes
Other Study ID Numbers: 2013-796
ID-RCB ( Other Identifier: 2013-A00626-39 )
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Keywords provided by Hospices Civils de Lyon:
dyslexia
training
auditory rehabilitation
hearing loss
evoked potentials
dichotic
plasticity
noise

Additional relevant MeSH terms:
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Language Disorders
Hearing Loss
Deafness
Neurodevelopmental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Communication Disorders
Neurobehavioral Manifestations